NCT04486261

Brief Summary

This study evaluates the effects of a high-intensity strength training in patients with myositis with the primary outcome being quality of life (SF-36). The study is designed as a parallel group randomised controlled trial with an intervention group and a control group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 24, 2020

Completed
1.1 years until next milestone

Study Start

First participant enrolled

August 30, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

April 10, 2024

Status Verified

April 1, 2024

Enrollment Period

6 months

First QC Date

July 17, 2020

Last Update Submit

April 9, 2024

Conditions

MyositisDermatomyositisPolymyositisImmune-Mediated Necrotizing Myopathy

Outcome Measures

Primary Outcomes (1)

  • Quality of life (health survey (SF-36) subscale: Physical Component Summary)

    Quality of life will be evaluated with the short form (36) health survey (SF-36) subscale: Physical Component Summary. The scale ranges from 0 to 100 where 100 is the highest score.

    16 weeks

Secondary Outcomes (23)

  • Leg power

    16 weeks

  • Handgrip strength

    16 weeks

  • Functional Index 3

    16 weeks

  • 30 seconds chair rise

    16 weeks

  • Timed up-and-go

    16 weeks

  • +18 more secondary outcomes

Other Outcomes (2)

  • Muscle biopsies

    16 weeks

  • Physical activity level

    16 weeks

Study Arms (2)

High-intensity strength training

EXPERIMENTAL

16 weeks of high-intensity strength training two times per week. Participants will receive the usual care in accordance to myositis (various DMARDs, different from patient to patient) Interventions: Other: high-intensity strength training Drug: Usual care

Other: High-intensity strength training

Control

NO INTERVENTION

Participants receive the usual care in accordance to myositis (various DMARDs, different from patient to patient). Intervention: Drug: Usual care

Interventions

High-intensity strength trainingOTHER

The high-intensity strength training protocol will consist of 2 training sessions per week. The first two weeks will be familiarisation training, where each exercise will be performed in three sets of 10 repetitions at an intensity of 15 repetitions maximum (RM). At week three each session will consist of 3 sets of each exercise corresponding to 10 RM, which will be kept for the remaining part of training intervention. The weights for each exercise will be adjusted throughout the intervention period, so the training load will correspond to 10 RM for each exercise in the entire intervention period.

Also known as: High-intensity resistance training
High-intensity strength training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fulfilling the criteria for myositis by EULAR/ACR (Bottai et al., 2017; Lundberg et al., 2017)
  • ≤ 5 mg/day Prednisolone

You may not qualify if:

  • Co-morbidity preventing resistance training (severe heart/lung-disease, uncontrolled hypertension (systolic \> 160mmHg, diastolic \> 100mmHg), severe knee/hip arthritis)
  • Alcohol- and/or drug abuse. Defined by the guidelines issued by The Danish Health Authority

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (5)

  • Bottai M, Tjarnlund A, Santoni G, Werth VP, Pilkington C, de Visser M, Alfredsson L, Amato AA, Barohn RJ, Liang MH, Singh JA, Aggarwal R, Arnardottir S, Chinoy H, Cooper RG, Danko K, Dimachkie MM, Feldman BM, Garcia-De La Torre I, Gordon P, Hayashi T, Katz JD, Kohsaka H, Lachenbruch PA, Lang BA, Li Y, Oddis CV, Olesinka M, Reed AM, Rutkowska-Sak L, Sanner H, Selva-O'Callaghan A, Wook Song Y, Vencovsky J, Ytterberg SR, Miller FW, Rider LG, Lundberg IE; International Myositis Classification Criteria Project consortium, the Euromyositis register and the Juvenile Dermatomyositis Cohort Biomarker Study and Repository (JDRG) (UK and Ireland). EULAR/ACR classification criteria for adult and juvenile idiopathic inflammatory myopathies and their major subgroups: a methodology report. RMD Open. 2017 Nov 14;3(2):e000507. doi: 10.1136/rmdopen-2017-000507. eCollection 2017.

    PMID: 29177080BACKGROUND

  • Lundberg IE, Tjarnlund A, Bottai M, Werth VP, Pilkington C, de Visser M, Alfredsson L, Amato AA, Barohn RJ, Liang MH, Singh JA, Aggarwal R, Arnardottir S, Chinoy H, Cooper RG, Danko K, Dimachkie MM, Feldman BM, Garcia-De La Torre I, Gordon P, Hayashi T, Katz JD, Kohsaka H, Lachenbruch PA, Lang BA, Li Y, Oddis CV, Olesinska M, Reed AM, Rutkowska-Sak L, Sanner H, Selva-O'Callaghan A, Song YW, Vencovsky J, Ytterberg SR, Miller FW, Rider LG; International Myositis Classification Criteria Project Consortium, the Euromyositis Register, and the Juvenile Dermatomyositis Cohort Biomarker Study and Repository (UK and Ireland). 2017 European League Against Rheumatism/American College of Rheumatology Classification Criteria for Adult and Juvenile Idiopathic Inflammatory Myopathies and Their Major Subgroups. Arthritis Rheumatol. 2017 Dec;69(12):2271-2282. doi: 10.1002/art.40320. Epub 2017 Oct 27.

    PMID: 29106061BACKGROUND

  • Jensen KY, Aagaard P, Suetta C, Nielsen JL, Bech RD, Schroder HD, Christensen J, Simonsen C, Diederichsen LP. High-intensity resistance training in patients with myositis - 1-year follow-up on a randomised controlled trial. Rheumatol Int. 2025 Apr 16;45(5):104. doi: 10.1007/s00296-025-05858-8.

    PMID: 40237840DERIVED

  • Jensen KY, Aagaard P, Suetta C, Nielsen JL, Bech RD, Schroder HD, Christensen J, Simonsen C, Diederichsen LP. High-intensity resistance training improves quality of life, muscle endurance and strength in patients with myositis: a randomised controlled trial. Rheumatol Int. 2024 Oct;44(10):1909-1921. doi: 10.1007/s00296-024-05698-y. Epub 2024 Aug 27.

    PMID: 39192022DERIVED

  • Jensen KY, Aagaard P, Schroder HD, Suetta C, Nielsen JL, Boyle E, Diederichsen LP. High-intensity strength training in patients with idiopathic inflammatory myopathies: a randomised controlled trial protocol. BMJ Open. 2021 Jun 25;11(6):e043793. doi: 10.1136/bmjopen-2020-043793.

    PMID: 34172544DERIVED

MeSH Terms

Conditions

MyositisDermatomyositisPolymyositis

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Study Officials

  • Louise Pyndt Diederichsen, PhD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Rheumatologist, Associate professor

Study Record Dates

First Submitted

July 17, 2020

First Posted

July 24, 2020

Study Start

August 30, 2021

Primary Completion

March 1, 2022

Study Completion

January 1, 2023

Last Updated

April 10, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Due to GDPR-regulations IPD will not be available.

Locations

DK(1)